Neurokinin Receptor Antagonist Associated to Ondansetron in PONV (PONV)
Primary Purpose
Postoperative Nausea and Vomiting
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Aprepitant
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring nausea, postoperative, postoperative nausea, postoperative vomiting, vomiting, postoperative
Eligibility Criteria
Inclusion Criteria:
- high risk patients for nausea and vomiting
Exclusion Criteria:
- cardiovascular disease, or hypersensibility to any of the drugs involved in the study
Sites / Locations
- Angela Maria Sousa
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
aprepitant
placebo
Arm Description
aprepitant 80 mg one hour before surgery
oral placebo one hour before surgery
Outcomes
Primary Outcome Measures
Incidence of nausea and vomiting in postoperative period
Secondary Outcome Measures
Full Information
NCT ID
NCT02357693
First Posted
January 31, 2015
Last Updated
August 24, 2015
Sponsor
Instituto do Cancer do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT02357693
Brief Title
Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
Acronym
PONV
Official Title
Effect of the Association of Neurokinin-1 Receptor Antagonist Aprepitant to Dexamethasone/Ondansetron in the Incidence of Postoperative Nausea and Vomiting in High Risk Apfel Score Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto do Cancer do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to determine whether patients at high risk for postoperative nausea and vomiting can benefit from aprepitant, ondansetron and dexamethasone in the perioperative period.
Detailed Description
High risk surgical patients for PONV, scheduled for laparoscopic surgery will be distributed in two groups: Group I will receive aprepitant 80 mg per os and Group II will receive placebo per os, one hour before surgery. In the operating room, patients will be submitted to combined intravenous general anesthesia plus spinal anesthesia. All patients will receive dexamethasone 4 mg and ondansetron 4 mg intravenously during the surgical procedure. After surgery, patients will be monitored for pain, nausea and vomiting during 24 hours.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
nausea, postoperative, postoperative nausea, postoperative vomiting, vomiting, postoperative
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aprepitant
Arm Type
Experimental
Arm Description
aprepitant 80 mg one hour before surgery
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
oral placebo one hour before surgery
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
Aprepitant or placebo will be administered to the patient before surgery
Primary Outcome Measure Information:
Title
Incidence of nausea and vomiting in postoperative period
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
high risk patients for nausea and vomiting
Exclusion Criteria:
cardiovascular disease, or hypersensibility to any of the drugs involved in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hazem a Ashmawi, phD
Organizational Affiliation
University of Sao Paulo
Official's Role
Study Director
Facility Information:
Facility Name
Angela Maria Sousa
City
Sao Paulo
State/Province
São Paulo
ZIP/Postal Code
01403010
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
25220550
Citation
Kawano H, Matsumoto T, Hamaguchi E, Manabe S, Nakagawa M, Yamada A, Fujimoto M, Tada F. Antiemetic efficacy of combined aprepitant and dexamethasone in patients at high-risk of postoperative nausea and vomiting from epidural fentanyl analgesia. Minerva Anestesiol. 2015 Apr;81(4):362-8. Epub 2014 Sep 15.
Results Reference
result
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Neurokinin Receptor Antagonist Associated to Ondansetron in PONV
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